FDA-Device2023-03-01Class II

Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

Siemens Medical Solutions USA, Inc
Hazard

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Sold states
US Nationwide distribution.
Affected count
7 units; Exanded recall: 215 units
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762473

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1168-2023

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